Nebulized Versus Intravenous Tranexamic Acid on Surgical Field Quality in Patients Undergoing Endoscopic Sinus Surgeries

Effect of Preoperative Nebulized Versus Intravenous Tranexamic Acid on Surgical Field Quality in Patients Undergoing Endoscopic Sinus Surgeries: a Randomized Controlled Comparative Study

Intraoperative bleeding is one of the vital problems for anesthesiologists and surgeons, during endoscopic nasal surgery; where the surgical field is very limited and surrounded by vital structures. The tinniest amount of blood in such surgical field can obscure the anatomy and clog the tip of the endoscope, requiring repeated irrigations and suctioning; both of which have traumatic effects on the friable nasal mucosa. Anesthetic techniques to minimize bleeding during endoscopic nasal surgery are of primary importance for a safe and effective procedure, reducing operative time and shortening post-operative recovery.

Good surgical conditions could be achieved with systemic, topical, or regional anesthetic techniques. The use of topical and regional techniques has been gaining popularity in recent years as an alternative to the administration of heavy premedication, high narcotic doses, intravenous lignocaine, clonidine, calcium channel blockers, sodium nitroprusside, beta-adrenergic blockers, and magnesium sulfate, which may produce a lack of alertness, respiratory depression, hypoxia, nausea and vomiting, and delayed recovery.

Recent studies have shown that the use of tranexamic acid could be a safe and effective management option for hemostasis in a wide range of specialties. Tranexamic acid (TXA) is a synthetic lysine derivative that blocks the lysine binding site on plasminogen, thus inactivating its conversion to plasmin and hence attenuating its fibrinolysis effects. When given as a one-time operative systemic dose, it can reduce intraoperative surgical blood loss. More recently, it has been used in its nebulized or topical form to treat bleeding in anatomically sequestered areas. Its use has been described for epistaxis, cancer-related hemoptysis, and post-tonsillectomy bleeding. Though systemic doses of tranexamic acid have proven their efficiency in reducing intraoperative bleeding, other forms of administration have not been widely researched. The use of nebulized form is expected to provide a targeted route and localized effect with reduced systemic side effects. Adverse effects of systemic administration of tranexamic acid include seizures, nausea, vomiting, diarrhea, pulmonary embolism, deep vein thrombosis, anaphylaxis, and other visual disturbance.

The purpose of this study was to assess the effect of pre-emptive nebulized tranexamic acid versus intravenous tranexamic acid on endoscopic visualization and bleeding rate during endoscopic sinus surgeries.

Study Overview

• Status: Recruiting
• Conditions: Intravenous; Surgical Field; Nebulization; Endoscopic Sinus Surgeries
• Intervention / Treatment: Drug: nebulized tranexamic acid; Drug: intravenous tranexamic acid

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Kareem MA Nawwar, M.D.; Phone Number: +201003878369; Email: drknawwar@cu.edu.eg

Study Locations

• Egypt
  • Cairo, Egypt
    • Recruiting
    • Faculty of medicine, Cairo University
    • Contact: Kareem MA Nawwar, M.D.; Phone Number: +201003878369; Email: drknawwar@cu.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Age between 18 and 60 years.
• American Society of Anesthesiologists (ASA) class I and II patients.
• Endoscopic sinus surgeries under general anesthesia.

Exclusion Criteria:

• Patient's refusal.
• American Society of Anesthesiologists (ASA) class III or IV patients.
• Underlying uncontrolled hypertension.
• Known history bleeding disorder.
• Patients on anticoagulant therapy.
• Allergy to any of the drugs utilized in this study.
• History of nonsteroidal anti-inflammatory drugs within 48 hours of scheduled surgery.
• Inadvertent intra-operative vascular injury.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Nebulized group; patients will receive nebulized tranexamic acid	Drug: nebulized tranexamic acid; patients will receive a preoperative nebulizer session of 500 mg of tranexamic acid. To ensure the blinding of the participating anesthetist and patient, patients in this group will receive an intravenous drip of 100 ml of 0.9% normal saline.
Active Comparator: Intravenous group; patients will receive intravenous tranexamic acid	Drug: intravenous tranexamic acid; patients will receive a preoperative intravenous drip of TXA at a dose of 15 mg/kg in 100 ml of normal saline. To ensure blinding this group patients will receive 5 ml of 0.9% normal saline nebulizer session.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The mean Wormald intraoperative surgical field grading	The mean value of Wormald intraoperative surgical field grading throughout the intraoperative period, where 0 means no bleeding and 10 means severe bleeding with nasal cavity filling rapidly	5 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total blood loss	calculated by measuring the volume of the blood in the suction reservoir minus the normal saline used to wash the surgical field	5 hours
Bleeding rate	calculated as the total blood loss divided by the surgical time	5 hours
Operation time	Time starting from induction of anesthesia till completion of the surgical procedure	5 hours
Postoperative complications	nausea, vomiting, anaphylaxis, visual impairment, seizure, venous thromboembolism	24 hours
postoperative nasal bleeding	Incidence of postoperative nasal bleeding	48 hours
postoperative intervention	Incidence of the need for postoperative intervention to control nasal bleeding	48 hours

Collaborators and Investigators

• Sponsor: Cairo University
• Investigators: Study Director: Kareem MA Nawwar, M.D., Cairo University; Study Chair: Nevan M Abbas Elmekawy, M.D., Cairo University; Study Director: Tamer M Khair, M.D., Cairo University; Principal Investigator: Nadia E M Gaballah, M.Sc., Cairo University

Study record dates

Study Major Dates

• Study Start (Actual): January 18, 2025
• Primary Completion (Estimated): June 15, 2025
• Study Completion (Estimated): July 1, 2025

Study Registration Dates

• First Submitted: January 11, 2025
• First Submitted That Met QC Criteria: January 11, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 19, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Antifibrinolytic Agents; Fibrin Modulating Agents; Hemostatics; Coagulants; Tranexamic Acid
• Other Study ID Numbers: MD-206-2024

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No